BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    OMRON ULTRASONIC NEBULIZER MODEL NE-UO5

    K Number: K864466 · Decision Mar 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    7
    Review Days
    134

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    Basic Information

    Device Name
    OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
    K Number
    K864466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Omron Tateisi Electronics Co.
    Date Received
    November 12, 1986
    Decision Date
    March 26, 1987
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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